The United States Food and Drug Administration (FDA) has approved PENMENVY, developed by GSK plc, as a meningococcal vaccine to protect against the five primary strains of Neisseria meningitidis: A, B, C, W, and Y. It is designed for individuals aged 10 to 25 years and brings major progress in disease prevention by reducing the number of required injections, thereby improving vaccination rates.
The PENMENVY vaccine combines two principal antigenic components derived from GSK’s licensed vaccines, BEXSERO and MENVEO. Clinical trial data from over 4,800 subjects on safety, tolerability, and immunogenicity supported its approval by regulatory authorities. Studies have shown that PENMENVY has a similar safety profile that aligns with existing meningococcal vaccines, reinforcing its suitability for widespread use. GSK Chief Scientific Officer Tony Wood welcomed the approval and said it would help to increase the vaccination rates, particularly among the serogroup B population, which remains under-vaccinated.
Invasive meningococcal disease (IMD) manifests as a severe bacterial infection with a fatality rate of one in six within the first 24 hours despite available treatments. The survival rate from IMD is high, but many patients maintain life-long disabilities, including brain injuries, amputated limbs, or hearing loss.
Behavioral choices among adolescents and young adults aged 16 to 23 years increase their chances of bacterial transmission and place them at greater risk of contracting the disease because of the living culture in close spaces and sharing food and drinks as well as engaging in kissing activities. The low rate of meningococcal serogroup B vaccination persists despite its safety concerns because only 13% of those eligible receive the full course, and 32% get at least one dose. PENMENVY offers a new vaccine that simplifies the process of administering vaccines by providing coverages for all five prevalent serogroups in one shot. This would allow high coverage and better compliance, which is the major challenge in immunizing teenagers and young adults.
Judy Klein, President and Founder of Unity Consortium, has welcomed this milestone because “the impact of meningococcal disease is severely devastating to those affected and their families.”
On February 28, 2024, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will consider adding PENMENVY to the existing immunization recommendations. National vaccination approaches and adolescent and young adult guidelines in the U.S. will be directly affected by the results of this upcoming meeting.
PENMENVY requires intramuscular delivery through two components, which include a lyophilized MenACWY formulation that requires MenB reconstitution before administration. The combined MenACWY and MenB components in PENMENVY lead to efficient, extensive coverage while simplifying the vaccine delivery process by eliminating the need for multiple separate doses.
PENMENVY shows strong safety performance but follows regular precautionary measures. The vaccine should be avoided by patients who have severe reactions to vaccine ingredients or past severe anaphylaxis reactions from diphtheria toxoid vaccinations. The most prevalent side effects during clinical trials involved injection site discomfort together with regular signs like fatigue, muscle pain, headache, and nausea. People who have weakened immune systems often show diminished protection from vaccinations.
As a leading pharmaceutical company, GSK maintains market leadership in meningococcal disease prevention. BEXSERO (more than 55 countries approve) and MENVEO (approved in over 60 nations) serve millions of children as they are used extensively throughout national immunization programs, resulting in over 190 million collective distributions.
The U.S. approval of PENMENVY positions GSK to deliver substantial advances to meningococcal vaccination strategies across the country, leading to transformative disease prevention practices for adolescents and young adults.
Healthcare professionals can now better combat IMD with this new approach. Preventive measures against the disease are made easier by the fact that it targets all five major serogroups and thereby is expected to help in improving immunization coverage and protecting more individuals. The next ACIP meeting will further discuss additional recommendations for its use in meningococcal prevention.
References: GlaxoSmithKline (GSK). PENMENVY, GSK’s 5-in-1 meningococcal vaccine, was approved by US FDA to help protect against MenABCWY. Published February 14, 2025. https://us.gsk.com/en-us/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/
